What you will be doing:
In the main role of Quality Complaints Specialist, you will be managing all routine activities for promoting and investigating customer complaints. Starting with registration and evaluating the reported events based on risk, all the way to investigations, implementation of action items, CAPA, ensuring reporting to authorities according to strict timelines and closure stage with all required evidence, including reports and analysis.
The role includes leading and participating in handling complaints weekly meetings, performing and providing data analysis, both in Word, PowerPoint or other formats, summarizing and capturing action items, and following up on their effective implementation until completion and closure.
You will take part in activities ensuring adherence to the Quality Management System, including improvement activities while assuring compliance is maintained.
Responsible for relevant procedures implementation.
Ensuring compliance with related regulatory requirements.
Getting and providing training in the relevant areas.
Supporting Global Objectives, Improvement projects and QA plans.
Reviewing and approving documentation. (such as procedures, protocols and reports).
Active participation in regulatory inspections (e.g. 21CFR820. ISO13485,MDD, CMDCAS, MDSAP, MDR), and other external and internal audits, including investigations and further CAPA/ corrections.
Supporting quality and company activities related with the job position and skills.
Requirements: What you have:
Bachelor's Degree in engineering, science or technical field or equivalent, Master's degree preferred.
One to three years of working experience in a highly regulated medical device industry (pharma and aerospace might also be considered) in one of the fields; quality, reliability or Regulatory.
Background in Quality Management Systems, internal/external audits, CAPA, Change Control, Complaint handling, Transfer from R&D to Production, Post Market Surveillance, supplier quality and design controls is preferred.
Working experience with applicable and regulatory standards (including, but not limited to: ISO13485:2016, MDD, and QSR). MDSAP and MDR knowledge is preferred.
High level of technical written English.
Ability to work in a team environment.
Working well in a fast-paced environment.
Ability to carry out various activities while consistently maintaining accuracy and attention to details.
Ability to work independently by implementing independent judgment and decision-making within the limits of established policies and procedures.
Organized and able to attain results on several projects simultaneously.
Ability to work well with a diverse group of people.
Process & Results oriented.
Self-starter.
Strong oral and written communication skills.
Advantages:
Experience with ERP systems and electronic QMSs.
Familiarity with customer feedback and complaints process.
Certified for performing internal audits.
This position is open to all candidates.
